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Pathogenic Bordetella Rapid Detection

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ClinicalTrials.gov Identifier: NCT04535505
Recruitment Status : Not yet recruiting
First Posted : September 2, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Tracking Information
First Submitted Date August 28, 2020
First Posted Date September 2, 2020
Last Update Posted Date September 2, 2020
Estimated Study Start Date October 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 28, 2020)
Accuracy of the new CPA platform based on CRISPR technology, including sensitivity and specificity [ Time Frame: At enrollment ]
Bordetella pertussis isolation culture and identification would be taken as gold standard. The enrolled subjects would receive the detection of this research platform detection method and the gold standard at the same time. The measurement indexes are sensitivity and specificity.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pathogenic Bordetella Rapid Detection
Official Title Establishment a Nucleic Acid Rapid Detection Technology Platform for Detecting Pathogenic Bordetella and Its Drug Resistance Genes
Brief Summary A CPA platform based on the CRISPR technology is going to established to achieve the goal of detecting pathogenic bordetella and drug resistance genes in one step. The accuracy of this platform will be checked through prospective diagnostic test evaluation methods. Bordetella pertussis isolation culture and identification would be set as a gold standard method.
Detailed Description

Pertussis is an acute respiratory infectious disease caused by bordetella pertussis. Although it is a vaccine-preventable disease, outbreaks and epidemic cases of whooping cough worldwide have been reported from time to time. Bordella parapertussis, Bodella bronchiseptica, and bordetella hosei can cause pertussis-like diseases with symptoms similar to those of whooping cough. The clinical manifestations are difficult to distinguish, and they are easily reported as cases of whooping cough through the infectious disease network.

The diagnosis of the infectious diseases caused by the four pathogenic bodella mainly relies on laboratory pathogenic testing. At present, the laboratory tests of bordetella that can be carried out in the clinical microbiology laboratory include culture, bordetella pertussis specific antibody (PT-IgG) serological detection, and bordetella pertussis nucleic acid PCR detection. However, none of them meet the requirements of early diagnosis.

Cross primer constant temperature amplification (CPA) is nucleic acid constant temperature amplification technology with independent property rights. The fully automated nucleic acid detection platform equipped with CPA technology would make the detection of four pathogenic bordetella easy, quick and safe and accurate.

As pathogenic bodella is difficult to cultivate and there is no standard for drug susceptibility test. Studies have shown that 57.4% of the isolated clinical isolates of bordetella pertussis have MIC value for erthomycin ≥256 μg/mL , and 23s rRNA 2047 site adenine (A) were mutated to guanine (G).CRISPR/Cas is an immune system in bacteria that can specifically recognize invading nucleic acids and shear them. The CRISPR technology developed based on the CRISPR/Cas principle can detect single point mutations in genes.

The hypothesis that 4 pathogenic bordetella and their erythromycin resistance would be detected in one testing platform simultaneously. The accuracy, reliability, predictive value of this platform would be checked through prospective diagnostic test evaluation methods. Bordetella pertussis isolation culture and identification would be as the gold standard method.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Nasopharyngeal swab of a suspected pertussis patient
Sampling Method Non-Probability Sample
Study Population 600 cases of suspected pertussis clinically diagnosed in the outpatient clinic and ward of Children's Hospital of Fudan University would be enrolled. The enrollment would start in October 2021 and end in June 2022. Patients who are admitted to the Children's Hospital of Fudan University during the enrollment period and are clinically suspected of pertussis would be the research objects. There are no special requirements for gender of the enrolled patients.
Condition Pertussis
Intervention Diagnostic Test: Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technology
This is an observational study and there are no interventions. The purpose of the study is to compare the accuracy (including sensitivity and specificity)of the new CPA platform based on CRISPR technology detection method and the gold standard in detecting pertussis patients.
Study Groups/Cohorts pertussis test population
People with clinical diagnosis of suspected pertussis in outpatient and ward in the Children's Hospital of Fudan University will be collected as study subjects. Their nasopharyngeal swabs will be collected. Bordetella isolation culture and identification method is the gold standard, and the new CPA platform based on CRISPR technology is the method to be tested. Diagnostic values of this research platform would be detected.
Intervention: Diagnostic Test: Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 28, 2020)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with continuous cough (paroxysmal cough) for more than 1 week, peripheral white blood cell 18×109/L (infants and young children), or> 15×109/L (children), ineffective use of cephalosporin antibacterial drugs,and these patients whose nasopharyngeal swabs are collected for routine bordetella culture identification and drug susceptibility testing would be included as research object.

Exclusion Criteria:

  • Patients with pertussis are suspected clinically but no nasopharyngeal swab specimens are collected or patients with pertussis are clinically excluded.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Chuanqing Wang, Phd +86 18017591167 Chuanqing523@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04535505
Other Study ID Numbers BRD1.0
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Children's Hospital of Fudan University
Study Sponsor Children's Hospital of Fudan University
Collaborators Not Provided
Investigators
Study Director: Chuanqing Wang, Phd Children's Hospital of Fudan University
PRS Account Children's Hospital of Fudan University
Verification Date August 2020